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When to use a Sinker

Posted by Pam Bialiy on

When to use a Sinker

The following article has been authored by John Heaney. Not all tablets, capsules, and gelcaps behave the same in dissolution media.  In some cases, a dosage may be buoyant enough to move far more than normal when subjected to the turbulence caused by a paddle (Apparatus 2) if not float all the way to the surface.  Either of these would be considered unacceptable if they were observed during a test. The case of a dosage form floating to the surface is obvious.  It’s far out of position from the bottom of the dissolution vessel and is not subject to the...

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Precision Molded vs Standard Glass Vessels

Posted by Pam Bialiy on

Precision Molded vs Standard Glass Vessels

The following article has been authored by John Heaney.   Variability is a fact of life in any manufacturing process.  That is the reason there are acceptance ranges and tolerances as well as QC departments to measure finished product ensuring that everything is acceptable.  The tools used by any QC department need to be as consistent as possible.  A pair of calipers that gives a slightly different reading each time when measuring an NIST standard block is not particularly valuable.  The same is true of dissolution testers, or more specifically vessels, that have high variability. High variability in the vessel...

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Filter Equivalence Studies

Posted by Pam Bialiy on

Filter Equivalence Studies

The following article has been authored by John Heaney.  Filtering is a required step in processing dissolution samples as it both stops the dissolution of larger particles by separating them from the sample and removes any material that may interfere with the analysis by UV/Vis spectroscopy, HPLC, or UPLC.  There are a plethora of materials, shapes, sizes, and porosities available to choose from to ensure that a filter is appropriate for a specific method.  In many cases it’s possible to find equivalent filters from other suppliers.  However, that equivalence needs to be proven, ideally during the development of the dissolution...

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Cleaning Stainless Steel

Posted by Pam Bialiy on

Cleaning Stainless Steel

The following article has been authored by John Heaney. Dissolution components are often made of 316 Stainless Steel (316 SS) or equivalent as it is a material specified in USP <711> for the construction of both Apparatus 1 (Baskets) and Apparatus 2 (Paddles).  316 SS has a reputation for being impervious to corrosion but that is not the case as it is merely resistant to corrosion.  It requires care and maintenance just like any other item in the lab. 316 SS’s corrosion resistance is due to the inclusion of additional Molybdenum to the mixture for the steel.  This means compared...

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